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Completed

NCT Number: NCT00392587

A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)

The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess its affects on their COPD disease after 14 days.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Chronic Obstructive Pulmonary Disease (COPD) Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Hanover, Lower Saxony, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women of childbearing potential
  • Established history of COPD
  • Cigarette smoking history greater than 10 pack years
  • FEV1 between 40 and 80% of predicted normal for height, age and sex.

Exclusion criteria

  • Morbidly obese patients (body mass index >40)
  • Hospitalisation or treatment for worsening of COPD in past 6 weeks
  • History of increased liver function tests
  • hypersensitivity to salbutamol or ipratropium bromide
  • Blood pressure > 155/95

Treatment and study plan

GW856553

Drug

Primary outcomes

  1. Measurements of adverse events, changes in heart rate, blood pressure, blood tests, heart function and lung function throughout the 14 day study. Exacerbations of COPD over the 14 day study.

    Time frame: 14 days

Secondary outcomes

  1. Inhibition of inflammatory agents in the blood after 7 and 14 days of dosing.

    Time frame: after 7 and 14 days of dosing

  2. Concentration of the drug in the blood after 1, 3, 7, 10 and 14 days of dosing.

    Time frame: after 1, 3, 7, 10 and 14 days of dosing

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled Parallel Study to Assess the Safety, Tolerability,Pharmacodynamics and Steady State Pharmacokinetics of Repeated Doses of GW856553 in Patients With COPD

Important dates

Study start
2006
First posted
Oct 26, 2006
Registry last updated
Jun 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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